Within the prior art, a couple of different transcutaneous vascular access systems are disclosed, of which some are disclosed in WO 01/032141, WO 97/047338, WO00/40282, WO 99/020338, WO 98/31272, WO 98/51368, WO 99/34852, U.S. Pat. Nos. 4,321,914 and 4,543,088. However, many of these have entered clinical practice with contradictory and pivotal results. The main problems raising is this context, i.e. infections, biofilm, device failure after repeated use to high for routine applications.
The drawbacks of prior art are clearly related to enhanced risk of infection mainly pocket infection around the implant. Due to repeated puncture, the integrity of the skin is resolved and bacteria can penetrate in the space between the artificial device and surrounding tissue. If an inflammatory process is started, the fibrosis response is enhanced and therefore a fibrous capsule around the implant is created. Bacteria will fill the intermediate phase between the fibrous cap and the surface of the implanted device over time and a biofilm is developing which finally leads to repeatedly occurring serious infections. This can only be treated by direct injection of antibiotics or disinfections fluids. Basically people are using lavage techniques as applied for major wound care, e.g. by applying fluids containing antibiotics or e.g. taurolidine. Due to the high risk of infection and deposition of bacteria, the risk for coagulation in the device is also increasing. Patients being dependent on these devices are exposed to a great risk to get severe infection complications, e.g. sepsis which may lead to long hospitalisation or even death of the patient. In addition, usually such access devices are used for patients where the vascular alternatives for blood access, i.e. vascular sites for new access constructions, are exhausted and the creation of a port system is the ultimate solution to get blood access needed for life saving extracorporeal therapies. If problems arise there is a great risk that the transcutaneous vascular access system has to be removed, which makes a further extracorporeal treatment more difficult or even impossible.
Accordingly, the main problems with these systems are that (i) the procedures to place these devices are difficult and frequently demanding revision of the access, committant and prophylactic use of antibiotics and disinfectants or major surgery, (ii) they easily give rise to infections and especially pocket infections around the devices, (iii) they have an inconsistent care hygiene and (iv) they require a relatively complex connection procedure. It is obvious that the state of the art devices missing important biological process enabling routine and medically acceptable access. Although these infections are treatable by lavage or antibiotics, this give rise to skin erosion, compromised wound healing, trauma relieve, and skin damage by repeated disinfections, entering a vicious circle of infections, bad healing, followed skin erosion, etc.